- AbbVie's oncology ambitions have run into another failure. The big biotech said Friday it has stopped a Phase 3 brain cancer study early after an interim analysis showed its experimental antibody drug conjugate brought no survival benefit over placebo.
- The early review was based on data from 639 patients with newly diagnosed, EGFR-amplified glioblastoma, an aggressive type of brain tumor. Enrollment for all other studies of depatuxizumab mafodotin, also called ABT-414, has been halted as well, the company said.
- While the experimental cancer therapy was developed by AbbVie, the company in-licensed components for the drug from Seattle Genetics and Life Science Pharmaceuticals.
Oncology has grown into a leading priority for drugmakers, pairing a steady flow of medical breakthroughs with huge market potential. AbbVie's success in establishing a presence in cancer has been modest, although not for a lack of effort.
The biotech has two cancer drugs on the market in Imbruvica (ibrutinib) and Venclexta (venetoclax), both of which treat various forms of leukemia and lymphoma. Excluding Humira (adalimumab), Imbruvica was AbbVie's best-selling drug last year, posting nearly $3.6 billion in global sales. It gained rights to Imbruvica through through the takeout of Pharmacyclics in 2015 for $20.8 billion.
Imbruvica and Venclexta were first approved in 2013 and 2016, respectively, leaving AbbVie without a new cancer product in the last few years. AbbVie aimed to make oncology a major growth platform when it followed the acquisition of Pharmacyclics with that of Stemcentrx in 2016 for $5.8 billion.
But the biotech has absorbed a string of clinical disappointments in the process.
In 2017, its experimental PARP inhibitor veliparib failed two late-stage clinical trials, while AstraZeneca led that therapeutic space with Lynparza (olaparib).
Rova-T (rovalpituzumab tesirine) was a critical asset from Stemcentrx. After a Phase 3 setback last December, AbbVie took a $4 billion impairment charge at the beginning of this year related to Stemcentrx. At the time, the biotech said it would monitor the remaining $1 billion in intangible assets from that deal for further impairment.
And now, ABT-414, also called Depatux-M, has fallen short in a particularly hard-to-treat cancer type. The pharma did not disclose specific results, but said they would be submitted for publication. Bristol-Myers Squibb also announced a Phase 3 trial failure in glioblastoma for its flagship immunotherapy, Opdivo (nivolumab).
AbbVie still has time to progress its oncology pipeline, particularly as it ended a legal battle this week that could have threatened Humira's market exclusivity in the U.S. The company has lined up deals with eight biosimilar developers to prevent U.S. entry until 2023.